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U.S. Department of Health and Human Services

Class 1 Device Recall Naturalyte Liquid Bicarbonate Concentrate

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 Class 1 Device Recall Naturalyte Liquid Bicarbonate Concentrate see related information
Date Posted May 22, 2014
Recall Status1 Open
Recall Number Z-1639-2014
Recall Event ID 67922
510(K)Number K071387 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle
Part Number: 08-4000-LB

The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Code Information Lot Numbers (49 lots) recalled on 4/10/14:
13KMLB001
13LMLB001
14AMLB002
13KMLB002
13LMLB002
14AMLB003
13KMLB003
13LMLB003
14AMLB004
13KMLB004
13LMLB004
14AMLB005
13KMLB005
13LMLB005
14AMLB006
13KMLB006
13LMLB006
14AMLB007
13KMLB007
13LMLB007
14AMLB008
13KMLB008
13LMLB008
14AMLB009
13KMLB009
13LMLB009
14AMLB010
13KMLB010
13LMLB010
14AMLB012
13KMLB011
13LMLB011
13JMLB005
13KMLB012
13LMLB012
13JMLB008
13KMLB013
13LMLB013
13JMLB006
13KMLB014
13LMLB014
13JMLB007
13KMLB015
13LMLB015
13JMLB004
13KMLB016
13LMLB016
13KMLB017
14AMLB001
Expanded Recall (9 lots):
13LMLB005
13LMLB006
14AMLB011
14AMLB013
14AMLB014
14AMLB015
14AMLB016
14AMLB017
14BLMB001
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
800-662-1237
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall
Naturalyte Liquid Bicarbonate maybe contaminated
FDA Determined
Cause 2
Under Investigation by firm
Action Fresenius Medical Care North America issued an Urgent Medical Device Recall Letter dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately and determine whether they have any of the affected parts on hand. If customers have the affected product, they were instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers will be instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product. Firm will also conduct 100% telephone calls. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188. Fresenius Medical Care sent an Urgent Expanded Medical Device Recall letter on May 1, 2014 for 9 additional lots. Customers were instructed to complete and return the attached FAX BACK FORM to confirm that they have received the notice and to indicate whether or not they have the affected product in their possession. For questions regarding this recall call 800-662-1237. Firm issued Press on 5/21/14.
Quantity in Commerce 672,784 units
Distribution Worldwide Distribution - USA (nationwide) and Canada.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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